The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Diapex.
Device ID | K033585 |
510k Number | K033585 |
Device Name: | DIAPEX |
Classification | Resin, Root Canal Filling |
Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
Contact | Benjamin Lichtenwalner |
Correspondent | Benjamin Lichtenwalner BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
Product Code | KIF |
CFR Regulation Number | 872.3820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-11-13 |
Decision Date | 2004-01-16 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIAPEX 78325011 3107596 Live/Registered |
DiaDent Group International Inc. 2003-11-07 |
DIAPEX 76540164 not registered Dead/Abandoned |
Gordon Tang Company, Inc. 2003-08-11 |